Lithium Carbonate
- Product NDC
- 0378-1300
- 11-digit product format
- 003781300
- Labeler code
- 0378
- Product ID
- 0378-1300_4dea5284-2539-43e3-8002-fed27008f189
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lithium carbonate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202288
- Marketing category
- ANDA
- Marketing start
- 2012-07-02
- Marketing end
- 0000-00-00
- Substance
- LITHIUM CARBONATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LITHIUM CARBONATE | ACTIVE INGREDIENT | 2BMD2GNA4V | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| LITHIUM CATION | ACTIVE MOIETY | 8H8Z5UER66 | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-1300 | LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 11 | Legacy NDC | 20240210_785a0327-998b-4154-9461-b72cb78e2739.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-1300-01 | 00378130001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-01) | 2012-07-02 | 0000-00-00 | No | No | Current |
| 0378-1300-05 | 00378130005 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-05) | 2012-07-02 | 0000-00-00 | No | No | Current |